Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201750782433 Date of Approval: 21/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy And Safety of Levamisole in African Children With Nephrotic Syndrome: A Protocol For A Double-Blinded, Standard of Care-Controlled Randomized Trial (ESOLAC TRIAL)
Official scientific title Efficacy And Safety of Levamisole in African Children With Idiopathic Frequent Relapsing And Steroid Dependent Nephrotic Syndrome: A Protocol For A Double-Blinded, Standard of Care-Controlled Randomized Trial (ESOLAC TRIAL)
Brief summary describing the background and objectives of the trial Most Idiopathic Nephrotic Syndrome patients are responsive to steroids but the course is characterized by frequent relapses necessitating prolonged steroid therapy which may lead to toxicity. Steroid sparing drugs, including levamisole have been recommended in current guidelines but few clinical trials have been conducted with levamisole in Africa. This protocol is designed to evaluate the efficacy and safety of levamisole against the standard of care using a double-blinded randomized clinical trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESOLAC TRIAL
Disease(s) or condition(s) being studied Kidney Disease,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 28/02/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 72
Recruitment status Active, not recruiting
Publication URL www.themping.org
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Levamisole arm The levamisole arm will receive levamisole at 2.5mg/kg on alternate days for 6 months after achieving remission using the standard regimen of 6 weeks of daily prednisolone at 60 mg/m2/day to a maximum of 60 mg daily, then alternate-day prednisolone at 40 mg /m2/day to a maximum of 40 mg for 6 weeks, and taper at 10 mg/m2/week for over 4 weeks. 10 months Levamisole is a cheap and relatively safe anti-helminthic agent is one of the several alternative medications found useful as a steroid-sparing agent in treating steroid-sensitive Nephrotic Syndrome (SSNS) as it prolongs periods of remission. In low- and middle-income countries in Africa patients may not afford the expensive alternative immunosuppressive agents. Therefore levamisole may be a useful alternative. 36
Control Group Standard of care This arm will receive 6 weeks of daily prednisolone at 60 mg/m2/day, then alternate-day prednisolone at 40mg /m2/day, and taper at 10 mg/m2/week for 4 weeks. Then participants will then receive 50 mg of vitamin C on alternate days for 6 months as a placebo. 10 months The comparator is the standard of care according to the Ibadan consensus guidelines. The standard of care is 6 weeks of daily prednisolone at 60mg/m2/day, then alternate-day prednisolone at 40mg /m2/day, and taper for 4 weeks. Glucocorticoids have remained the mainstay of treatment for NS since their introduction in the 1950s, and steroid responsiveness is regarded as its most important prognostic indicator. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children between the ages of 2 and 18 years as at the last birthday 2. Children with Steroid sensitive Nephrotic syndrome 3. Children with Idiopathic Nephrotic Syndrome 4. Children whose caregivers signed Informed consent for their participation in the study 1. Children with congenital anomaly of the urogenital system 2. Children with steroid-resistant nephrotic syndrome 3. Children who are receiving other immunosuppressive drugs 4. Children with End-Stage Renal Disease. 5. Children with Co-morbid conditions OR Systemic disease Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/01/2022 University of Nigeria Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Enugu Port Harcourt Expressway, Ituku Ozalla Enugu State Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Number of Relapses in a period of 12 months post-randomization 2. Period of sustained remission within 12 months post-randomization. 12 months
Secondary Outcome 1. Number of subjects in remission at 6, 12, and 18 months post-randomization 2. Number of solicited and unsolicited adverse events and serious events at 6, 12, and 18 months post-randomization 6, 12 and 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigerian Teaching Hospital UNTH, Enugu Port Harcourt Express Way, Ituku Ozalla, Enugu Enugu 400001 Nigeria
University College Hospital Ibadan Queen Elizabeth Road Ibadan 200221 Nigeria
University of Uyo Teaching Hospital Abak Rd,Uyo Uyo 532101 Nigeria
Rivers State University Teaching Hospital 5-7 Harley Street, Port Harcourt Port Harcourt 500241 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
The Molecular Pathology Institute 44 Rangers Avenue, Independence Layout Enugu Enugu 400001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Molecular Pathology Institute 44 Rangers Avenue Independence Layout Enugu Enugu 400001 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Safety Molecular Pathology Laboratory 44 Rangers Avenue, Independence Layout Enugu 400001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Henrietta Okafor Henrietta.okafor@unn.edu.ng +2348033218687 UNTH Enugu Port Harcourt Express Way, Ituku Ozalla
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria University of Nigeria Enugu Campus
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Nna e.nna@themping.org +2347063415385 44 Rangers Avenue Independence Layout Enugu
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria The Molecular Pathology Institute
Role Name Email Phone Street address
Public Enquiries Adanze Asinobi adasinobi@yahoo.com +2348038955880 Queen Elizabeth Road
City Postal code Country Position/Affiliation
Ibadan 200221 Nigeria University College Hospital Ibadan
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results from this study including interim analysis will be shared with the Local Ethics Committee, Data and Safety Monitoring Board DSMB, and participants' Physicians. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months Controlled access to electronic medical records, CRFs and ICF. Only authorized persons will have access to anonymized data including the CRO handling the trial. All data are anonymized to investigators and outcome assessors.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.themping.org/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information